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In this phase II study, TC patients previously treated with platinum\u2010based chemotherapy were enrolled. The patients received S\u20101 orally twice daily at a dose of 40\u201060\u00a0mg\/m<jats:sup>2<\/jats:sup> for 4\u00a0weeks, followed by 2\u00a0weeks off until the progression of the disease or the presence of unacceptable toxicities. The primary endpoint was the objective response rate (ORR), and secondary endpoints were progression\u2010free survival (PFS), overall survival (OS), and safety. The sample size of 26 patients was planned to reject the ORR of 10% under the expectation of 30% with a power of 0.80 and a type I error of 0.05 (one\u2010sided). Twenty\u2010six patients were recruited between 2013 and 2016; 23 patients had squamous cell carcinoma and 10 had an ECOG performance status of 0. One patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (90% confidence interval [CI], 18.3\u201046.9) and an 80.8% disease control rate (90% CI, 65.4\u201090.3). The median PFS was 4.3\u00a0months (95% CI, 2.3\u201010.3\u00a0months) and median OS was 27.4\u00a0months (95% CI, 16.6\u201034.3). Adverse events of grade\u00a0\u2265\u00a03 included neutropenia (12%), skin rash (8%), elevated alanine aminotransferase, and fatigue (4%). No treatment\u2010related death was observed. S\u20101 confirmed clinical activity with tolerability in patients with previously treated TC. 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